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International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

Study acronym: IMPACT
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Sep 30, 2024 to Oct 24, 2024
    • Study completion date: Sep 30, 2025 to Aug 2025
    v9
  2. Enrollment target: estimated 400 to confirmed 405
    • Primary completion date changed from estimate of Oct 30, 2024 to Sep 30, 2024
    • Study completion date: Jun 30, 2025 to Sep 30, 2025
    • Study sites revised (32)
    v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 32 of 32 sites
    v7
  4. Enrollment target: 200 to 400v6 Show 7 more changesShow less
    • Primary completion date: Apr 5, 2022 to Oct 30, 2024
    • Study sites: 19 to 32
    • Study completion date: Oct 5, 2024 to Jun 30, 2025
    • Start date: Dec 2, 2020 to Dec 21, 2020
    • Eligibility criteria expanded, about 219 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study arms: 0 to 2
  5. Study sites: 5 to 19
    • Secondary endpoints revised (2)
    • Study description revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Dec 31, 2020 to Dec 2, 2020
    v4
  2. Start date: Nov 5, 2020 to Dec 31, 2020v3
  3. Start date: Oct 5, 2020 to Nov 5, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
Trial Details
NCT Number NCT04572230
Lead Sponsor Stryker Neurovascular
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 405 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov